Post-market Study of the Biodesign Hernia Graft

NCT04294446 | Terminated Results FDA Device

• 1 other identifier: 19-004
• Study Type: observational
• Target: 74
• Locations: 2 countries
• Sites: 3

Brief Summary

The purpose of this study is to collect data on the performance of the Biodesign® Hernia Graft when used to reinforce soft tissues during ventral hernia repair.

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (1)

• Hernia Recurrence

  Hernia recurrence through 1-year follow-up

  1-year

Secondary Outcomes (8)

• Device-, Procedure-, and Hernia-related Adverse Event Rates

  2-year

• Hernia Recurrence Rate Through 2-year Follow-up

  2-year

• Operative Times

  During operation

• Hospital Stays for Serious Adverse Events

  2-year

• Hospitalization Times for Related Serious Adverse Events (SAEs)

  From date of hospitalization for SAE. Patients were followed up to 2 years.

Interventions

Biodesign Hernia Graft DEVICE

The Biodesign Hernia Graft is comprised of 8 layers of decellularized porcine small intestinal submucosa (SIS) that has been pressed-lyophilized (i.e., freeze-dried under vacuum pressure) to laminate the component sheets (i.e., layers) together. In addition, it is perforated and sewn with 4-0 Trisorb suture (polyglycolic acid (PGA); Samyang Corporation, Seoul, South Korea). The suture is distributed in a diamond pattern across the graft and along the periphery and is intended to mitigate delamination of the layers upon rehydration and/or manipulation during implantation. Being a completely biologic device, the Biodesign Hernia Graft is considered MR safe.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who meet all of the inclusion criteria and none of the exclusion criteria will be invited to participate in this study.

You may qualify if:

• \. Primary or recurrent ventral hernia in need of surgical repair utilizing a Biodesign Hernia Graft

You may not qualify if:

• Known sensitivity to porcine material
• For the study, the following patients will also be excluded:
• Age \< 18 years
• Unable or unwilling to provide informed consent
• Life expectancy of less than one year from the date of the index procedure
• Patients will be excluded from the study if they never receive a Biodesign Hernia Graft during their index procedure.

Sponsors & Collaborators

• Cook Biotech Incorporated: lead

Study Sites (3)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Queen Elizabeth II Hospital

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Rae Ritchie
• Organization: Cook Biotech Incorporated (d/b/a Evergen)

rritchie@evergenbio.com

765-497-3355

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 4, 2020
• Study Start: November 10, 2020
• Primary Completion: November 26, 2024
• Study Completion: November 26, 2024
• Last Updated: March 12, 2026
• Results First Posted: March 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (2)